Newsletter | September 16, 2025

09.16.25 -- Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

SPONSOR

Webinar: Streamlining Biologics Development: Leveraging Small-Scale Studies for Greater Efficiency

Join Samsung’s expert-led webinar to discover how small-scale downstream process studies transform biologics manufacturing. Learn how data-driven approaches accelerate tech transfer, strengthen validation, and streamline regulatory approvals. Through real-world case studies, see how these studies reduce risks, save resources, and drive higher product quality—helping you bring safe, effective therapies to market faster and more efficiently. Click here to learn more.

FOCUS ON OUTSOURCING

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

Your Most Pressing Tech Transfer Questions Answered

No two tech transfers are the same. To ensure success with yours, select a CDMO that will be astute in their onboarding analysis and commit to ongoing collaboration.

Utilizing Small-Scale Downstream Studies Across Biologics Manufacturing

Small-scale downstream studies play a critical role in enabling efficient, low-risk tech transfer for biologics development.

How To Bring (Any) mRNA To Life: Simplifying Nucleic Acid Encapsulation

New technologies for the encapsulation of nucleic acids, such as FDmiX, can potentially overcome limitations of currently available standard mixing technologies.

Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids

Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

Achieving Rapid, High-Titer Expression For Next-Generation Biologics

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Enabling Commercial AAV Manufacturing By AAV Stable Producer Cell Lines

A high-performance, helper virus-free stable producer cell line is derived from proprietary high-producer HEK293 cells and is cultivated in a chemically defined, serum-free, ADCF medium in suspension.

Unlocking The Potential Of Your Sterile Injectables With Exact SI-ence

Sterile injectables present multiple hurdles on the path from early clinical phases to commercial. Learn how a partner with extensive capabilities and expertise can help streamline the path to market.

OUTSOURCING SOLUTIONS

CMC Manufacturing And Analysis - Labcorp Biopharmaceutical CMC Services

Antibody Discovery & Engineering Services - Curia

Leveraging Biologics Analytical Services - Alcami

Formulation And Analytical Tour - Nanoform

Get Quality Components Delivered Quickly - West Pharmaceutical Services, Inc.

Connect With Bioprocess Online: